# K182521: FastPack IP Sex Hormone Binding Globulin Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Qualigen, Inc.
- Decided: Jan 29, 2019 after 138 days
- Product code: CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone)
- Device class: 1
- Regulation: 21 CFR 862.1680
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K941797 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083867: Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding Globulin Calibrators and Access Sex Hormone Bind, Beckman Coulter, Inc. (2009) Summary page 5.

## Recalls of this device
- Dec 3, 2024 · Class III · Z-0805-2025: Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, 
- Nov 6, 2019 · Class II · Z-1672-2020: The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasm

## Indications for use
FastPack® IP SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack® System. The FastPack® IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.

Source page: https://510kreport.com/device/K182521
Methodology: https://510kreport.com/methodology